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dennis100
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« Reply #30 on: September 03, 2017, 01:17:06 AM »

Model Number 103
Event Date 12/13/2011
Event Type  Injury   
Event Description
On (b)(6) 2012, a vns implanting surgeon's nurse reported that the vns patient was complaining of pain in the left axillary/pectoral area and stating that the vns moves occasionally. The patient has had physical therapy to see if it would help with the discomfort but it did not. The patient was going to have surgery to either reposition or replace the battery. The nurse stated that the patient first reported the pain on (b)(6) 2011. The patient had surgery on (b)(6) 2012 and the surgeon just repositioned the generator and did not replace it. The operation notes from the surgery reveal that the patient has been experiencing this pain at the generator site over the past several months. The pain was exacerbated by movement at her shoulder. The surgeon stated that x-rays showed no evidence of malposition or break in the wire and that diagnostics show no evidence of functional problems. Because of the pain, the patient underwent reposition of the generator. After the generator was repositioned, diagnostics were still within normal limits. Attempts for additional information from the surgeon were made but no further information has been received to date. The implanted product information has been requested from the hospital but has not been received.
 
Manufacturer Narrative
Additional information was received regarding the product information therefore updating the information reported on the initial report.
 
Event Description
On (b)(6) 2012 the patient's implanted product information was received from the medical records department of the hospital the patient was implanted in.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2468877
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dennis100
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« Reply #31 on: September 18, 2017, 12:13:48 AM »

Model Number 103
Event Date 04/27/2012
Event Type  Injury   
Event Description
It was initially reported that the patient had their generator explanted due to an infection. The patient was recently implanted and the infection was likely related to surgery. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Good faith attempts for more information have been unsuccessful to date.
 
Event Description
Additional information was received that the infection was at the armpit and not where the generator was placed. There was no patient manipulation or trauma that contributed to the infection. Cultures were taken and results showed that they were pseudomonas species. They are planning to re-implant the patient but have not to date. Product analysis was completed on the generator. The device was returned due no malfunction suspected/identified and infection. Results of diagnostic testing indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
Additional information was received indicating the patient's culture results indicated gram negative bacteria. The bacteria originated from the armpit area. The patient had been put on cipro as intervention. The patient was indicated is now doing "fine" per the surgeon. Surgery to reimplant the patient with vns has occurred.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2613729
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dennis100
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« Reply #32 on: September 20, 2017, 01:15:16 AM »

Model Number 103
Event Date 06/22/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient's generator had migrated, and she was being referred for surgery. The patient was implanted with vns on (b)(6) 2012. Clinic notes dated (b)(6) 2012 indicated that generator had moved under the axillary region causing pain, pressure in the arm, and discomfort. The pain was indicated to be with movement. It was written that the patient would be referred to the surgeon to evaluate vns placement and make changes as needed. Additional information was received from the neurosurgeon after surgery consult revealing that the patient is experiencing numbness to the left arm due to the generator; moving around; the patient had generator replacement surgery on (b)(6) 2012 due to the generator migration. Attempts for product return have been unsuccessful to date. Attempts for additional information from the treating neurologist and implanting physician have been unsuccessful thus far. Additional information was however received on (b)(6) 2012 from the surgeon that performed the generator replacement which revealed that the migration caused the left arm pain and numbness. It was not believed the numbness was related to stimulation. It was not noted in the operative notes if the explanted generator appeared sutured down during generator replacement. However, it was confirmed that the replacement generator was secured to the pectoral muscle. The migration became symptomatic and quite painful before surgery for the patient which is why the patient had surgery. There was no indication of patient manipulation or trauma. No additional information was provided.
 
Event Description
It was reported that the explanted generator will not be returned for analysis, as the explanting facility requires patient signed release and they will not ask the patient at time of surgery, so therefore, this site will not return to manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2662284
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dennis100
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« Reply #33 on: September 21, 2017, 12:34:03 AM »

Model Number 102
Event Date 06/13/2012
Event Type  Injury   
Manufacturer Narrative
Initial reporter, corrected data: the initial mdr report inadvertently listed the incorrect initial reporter. The correct reporter and occupation are provided.
 
Event Description
Reporter indicated a patient was experiencing migration of the vns generator into the left axilla, along with painful vns stimulation in the chest. The migration occurred approximately (b)(6) 2012. The patient has also reported the vns lead was migrating, but the reporter confirmed only the generator was migrating. It was also reported the generator was at end of service. However, a battery estimate performed yielded 4 years remaining, indicating end of service is unlikely. The patient had no trauma and did not manipulate the vns. The vns generator was secured with a non-absorbable suture at the initial implant surgery on (b)(6) 2007. Surgery to replace the vns generator is tentatively planned for (b)(6) 2012. Attempts for further information are in progress.
 
Event Description
A manufacturer's implant card was received from the reporter indicating that vns device diagnostics were within normal limits with the resident lead and new vns generator at the (b)(6) 2012 surgery. The implant card indicated the generator was replaced for prophylactic reasons.
 
Event Description
Reporter indicated the patient was having some left pectoral pain, but this was not considered a serious injury. It was felt the generator had migrated over the previous 3-4 weeks. The patient had generator replacement surgery performed on (b)(6) 2012. Attempts for return of the explanted generator have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional manufacturer follow up with the hospital revealed the explanted vns generator was discarded after the surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2648409
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dennis100
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« Reply #34 on: October 11, 2017, 02:12:14 AM »

Model Number 102
Event Date 03/06/2013
Event Type Injury
Event Description
It was reported that the patient was hospitalized on (b)(6) 2012 to receive iv antibiotics due to an infection at the generator site. The patient had undergone generator replacement surgery on (b)(6) 2013. The generator was explanted on (b)(6) 2013 due to the infection. It was noted that wound cultures showed rare staphylococcus aureus and that blood cultures showed no growth for five days. The patient was discharged home on (b)(6) 2013 in stable condition on antibiotics. The patient was referred to an infectious disease physician. The surgeon plans to reimplant a new generator when the infection is cleared. It is unknown if there was any patient manipulation or trauma that occurred that could have caused or contributed to the infection. Attempts to obtain additional information have been unsuccessful to date.

Event Description
Further follow-up revealed that the patient was swollen in the axilla and neck area and as a precaution the patient was admitted to the hospital on (b)(6) 2013 for iv antibiotics. The physician indicated that at this time there was no obvious signs of infection at the site. The patient was then readmitted to the hospital on (b)(6) 2013 with signs of infection and both generator and lead were then explanted. The physician indicated that the patient scratched at the site which could have caused or contributed to the infection.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3038987
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dennis100
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« Reply #35 on: October 11, 2017, 02:13:44 AM »

Model Number 103
Event Date 03/12/2013
Event Type Injury
Event Description
On (b)(6) 2013, it was reported that this vns patient required a lead revision for an unknown reason. Follow-up showed that the surgery was for repositioning of the lead. During surgery on (b)(6) 2013, the patient's generator was in the axillary position and moved to chest area. It is unknown where in the chest the device was initially implanted. Attempts for additional information have been unsuccessful.

Manufacturer Narrative
Corrected data: previously submitted mdr indicated the patient was the operator of the device. Additional information was received indicating that the physician may have contributed to the error. This report is being submitted to correct this data.

Event Description
Additional information was received indicting that the patient was referred for surgery due to pain/pinching in her axillary area. It is unknown exactly when this began. The surgery was for patient comfort. No patient manipulation or trauma occurred that is believed to have caused/contributed to the event. A non-absorbable suture was not used to secure the generator to fascia during implantation of the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3043572
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dennis100
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« Reply #36 on: October 16, 2017, 12:20:55 AM »

Model Number 103
Event Date 01/31/2013
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(4) 2013 it was reported that the vns patient¿s vns generator migrated down into her armpit. It was later reported that the migration was noticed shortly after the patient¿s implant, approximately nine months ago. Surgery is planned but has not occurred to date to fix the migration issue. Diagnostics were performed on (b)(6) 2013 and the physician reported that the device seemed to be functioning properly. No patient manipulation or trauma was reported. At this point it is unknown if non-absorbable sutures were used to secure the generator to fascia during implantation. Good faith attempts were performed and it was later reported that the migration of the vns generator was first observed on (b)(6) 2013. No patient manipulation or trauma is believed to have caused the migration. However, it is still unknown at this point if non-absorbable sutures were used to secure the generator to fascia during implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3241521
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dennis100
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« Reply #37 on: October 18, 2017, 12:31:44 AM »

Model
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dennis100
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« Reply #38 on: October 23, 2017, 12:50:42 AM »

Model Number 102
Event Date 10/15/2013
Event Type Injury
Event Description
Generator analysis was approved on (b)(6) 2013. The pulse generator was explanted/returned due to ¿prophylactic replacement¿. The reported ¿failure to program¿ allegation was duplicated (not due to eos) in the pa laboratory at two orientations. Repositioning the wand resolved, and this it is not considered a device malfunction. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(6) 2013, this vns patient underwent prophylactic generator revision. The patient reported an increase in seizures, and the patient¿s neurologist was not able to interrogate the device. The device was believed to be at end of service, and the patient was referred for surgery. The patient had gained weight. The device could be programmed and interrogated successfully on the date of explant. Follow-up showed that the device was changed because it had migrated into the axilla. The device couldn't be interrogated due to the patient's habitus, and she could not tolerate prolonged searching secondary to her psychiatric problems. The most recent settings as of (b)(6) 2013 were provided. The physician stated that the failure to program occurred on (b)(6) "2031", and the physician was unable to do a normal mode test. This would not process. The vns was also very slow to interrogate. This was possibly caused by physical location of the vns. The generator was returned on (b)(6) 2013 and is pending analysis. An in-house battery life calculation showed 5. 63 years remaining.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3488430
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dennis100
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« Reply #39 on: October 23, 2017, 12:51:20 AM »

Model Number 103
Event Date 08/07/2013
Event Type Injury
Event Description
On (b)(6) 2013, it was reported that the patient's vns device was removed because the patient began having more frequent seizures after the vns was turned on. The patient did a trial with the vns device turned off and only had one seizures. The vns also caused discomfort in the left axilla. The patient and family wanted the device removed. The patient did very well post-op. Follow up with the physician found that they are reluctant to provide any additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3462536
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dennis100
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« Reply #40 on: October 26, 2017, 12:40:39 AM »

Model Number 105
Device Problem Migration of device or device component
Event Date 01/19/2014
Event Type Injury
Event Description
It was reported that the patient experienced fever and redness over the generator. The patient was seen and admitted for iv antibiotics. It was reported that the generator had migrated across the chest wall to the anterior axillary fold and that the skin was inflamed. It was reported that the patient had undergone generator replacement in (b)(6) 2013. It was reported that the patient would likely undergo surgical exploration. Further follow-up revealed that swabs taken have come back negative to infection. It was reported that the generator was removed and the wound was washed out and debrided. It was reported that the lead was buried in the wound and sutured in place. A non-absorbable suture was reportedly utilized to secure the generator during initial implant surgery. It was reported that the micro analysis is underway, but that it is highly likely infection.

Event Description
Additional information was received that no infection was found following first removal of device removed (b)(6) 2014.

Event Description
The generator was received for analysis on (b)(4) 2014. Analysis of the generator was completed on (b)(4) 2014. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
An implant card was received indicating that the patient underwent generator implant on (b)(6) 2014.

Event Description
It was reported that there are no signs of infection and that reimplant is being planned.

Manufacturer Narrative
Review of device manufacturing records. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3632721
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dennis100
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« Reply #41 on: November 03, 2017, 02:49:54 AM »

Model Number 103
Event Date 06/05/2014
Event Type Injury
Event Description
On (b)(6) 2014 it was reported that the patient had pocket revision surgery to correct the pain in july 2014 but that the pain started again recently. Now the patient is experiencing a headache, chest pain, and pain on the left side of the neck. The patient was referred for x-rays. The patient saw the neurologist on (b)(6) 2014 complaining of pain and per the neurologist, the lead is protruding in the armpit area. The neurologist did not have a programmer to turn off the vns. The neurologist referred the patient for surgery as the patient wants the vns removed. Although surgery is likely, it has not occurred to date. On (b)(6) 2014 it was reported that the physician had the vns turned off due to the patient¿s complaints of pain radiating up her neck, migraines, and pain at the generator site. The settings prior to being disabled were noted to be current output: 0. 25ma/frequency: 15hz/pulse width: 250usec/time on: 30 sec/time off: 1. 1 min/magnet output: 0. 50ma/mag time on: 60 sec/mag pw: 500usec. System diagnostics test was performed which showed lead impedance: ok/impedance value: 3647ohms/ifi: no. Attempts were made for further information but were unsuccessful.

Event Description
It was reported that the vns patient¿s generator had migrated toward the anterior axillary line. The patient had been experiencing some pain at her generator site. The patient did not have any fever, abrasions, or discoloration; however, the patient felt her generator was protruding into her armpit. The generator incision had healed well and the device was still functioning as expected. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3906342
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dennis100
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« Reply #42 on: November 11, 2017, 02:49:16 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 09/01/2017
Event Type Injury
Event Description
Clinic notes were received for generator replacement referral. Per notes, the patient reported that she feels her vns has been more painful lately, and wonders if it is not working any longer. At the previous clinic visit, she mentioned that her vns was not firing off for a couple hours (normally, she can feel it firing). It was reported to be working ok since then up until past two weeks, when she has been feeling pain in her left chest area, under her armpit, especially when the device fires. Patient also feels a wire present near the attachment to the device which was not noticeable to her previously. Patient has not had any injuries or falls which may have damaged the device. Patient compares this to a similar feeling she had before the batter was replaced previously. Patient's device was interrogated but no adjustments were made. The patient consulted with a surgeon who indicated that a generator replacement is recommended. The lead impedance was normal and so lead replacement is not needed. Impedance - 2424 ohms. The surgeon noted granulation tissue or lead wire close to the skin in the chest area. The incision was however well healed. No other relevant information was received. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6949677
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dennis100
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« Reply #43 on: November 14, 2017, 02:25:47 AM »

Model Number 103
Event Date 01/20/2015
Event Type Injury
Event Description
On (b)(6) 2015 the physician reported that the pain was first observed in (b)(6) 2014. No trauma or manipulation that preceded the onset of the pain. The intervention taken was that the generator was repositioned to the axilla.

Manufacturer Narrative

Event Description
It was reported that the patient was scheduled for a repositioning of the generator as the current position is painful. Good faith attempts for further information from the physician were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4513177
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dennis100
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« Reply #44 on: November 17, 2017, 03:44:19 AM »

Model Number 103
Event Date 10/01/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Clinic notes dated (b)(6) 2013, indicate the patient was seen back that day "poset" chess abscess at the vns pocket. The patient is doing well and shows no signs of infection. Sutures were removed. Clinic notes dated (b)(6) 2013 indicate that there were complications with the vns implant surgery which led to the infection. The infection required vns removal. An analysis was performed on the returned lead portions. The slice mark found on the outer silicone most likely provided the leakage path for the remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device. Results of diagnostic testing indicated that the battery status indicated ifi=no in the product analysis lab. The battery voltage was 2. 924 volts (not at ifi), as measured during completion of test parameter (b)(4) of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 1. 412% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
It was reported that the patient was going to undergo explant of the vns system on (b)(6) 2013 due to infection. It was reported that the patient has been on antibiotics. Further follow-up revealed that the patient was admitted to the hospital for iv antibiotic therapy and did not respond as well as the surgeon preferred. Clinic notes dated (b)(6) 2013 indicated that the patient had a right chest abscess with cellulitis. It was noted that the patient was doing well until 3 days prior when he noticed that his chest area became red and swollen and tender to touch. The patient was seen in the emergency room on (b)(6) 2013 and was found to have pus draining from the chest site. The patient was given antibiotics and sent home. The patient was seen by the physician on (b)(6) 2013 and a culture and sensitivity and gram stain were obtained. The gram strain was negative and the patient was admitted to the hospital for further antibiotic therapy. It was noted that the patient had bloody material draining from the wound at the anterior axilla region. The generator and lead were returned for analysis on 11/05/2013. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3479210
« Last Edit: December 19, 2018, 12:32:53 PM by dennis100 » Logged
dennis100
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« Reply #45 on: November 22, 2017, 03:24:30 AM »

Model Number 102
Device Problems High impedance; Migration of device or device component
Event Date 01/01/2015
Event Type Injury
Event Description
It was reported that the patient's generator had migrated from its original position to the patient's armpit whenever she moved in a certain way. The patient was seen by the physician and referred for surgery to correct the migration of the device. The physician noted that the generator does shift significantly under the skin in the left pectoral region. Manipulation of the pulse generator causes significant discomfort to patient in the chest and also some hoarseness of the voice. Additional information was received that no trauma or manipulation is suspected. Diagnostics were reported to be within normal limits with no high impedance. Patient underwent full revision surgery on (b)(6) 2015. Diagnostics were attempted but patient experienced left neck pain and coughing with stimulation. Upon opening generator pocket the surgeon felt that the lead wire was "corroded inside" and chose to replace the lead as well (reported in manufacturer report # 1644487-2015-04810). Upon opening the neck incision, surgeon noted that there was not adequate strain relief from the implant surgery and this caused "pulling and twisting" of the nerve. Both the generator and lead were replaced and post replacement diagnostics were within normal limits. The explanted generator is expected to be returned but has not yet been received by the manufacturer.

Manufacturer Narrative

Event Description
It was reported the hospital was able to find the explanted generator. The explanted generator was received by the manufacturer on 08/14/2015. Analysis is underway, but has not been completed to date. The explanted lead is captured in mfr. Report # 1644487-2015-04810.

Event Description
Additional information was received from the explant facility that the explanted products will not be returned.

Event Description
A user facility medwatch report (uf/importer report # (b)(4)) was received stating that the device was "shocking" the patient.

Event Description
Additional information was received that the patient continues to experience pain in the chest due to the presence of scar tissue. The physician noted a small area of prominence that follows in the path where the previously explanted lead was present. The physician felt the presence of possible scar tissue, and attributed this to patient's sensitivity and pain. The physician further attributed the presence of scar tissue to the corrosion of the explanted lead and the previous revision surgery. Physical therapy was recommended by the physician for the breakdown of scar tissue and for pain. The report of corrosion on the lead was previously reported in manufacturer report # 1644487-2015-04810.

Manufacturer Narrative
Describe event or problem; corrected data: the information regarding the return of the lead was originally and inadvertently reported in mfr. Report # 1644487-2015-04809, supplemental report #03.

Event Description
It was reported the hospital was able to find the explanted lead. The explanted lead was received by the manufacturer on 08/14/2015. Analysis is underway but has not been completed to date. New information was also received stating the voice hoarseness the patient experienced was sometimes caused by stimulation.

Manufacturer Narrative
The supplemental 04 mfr report was stated to be 09/13/2014. This was mistakenly reported and the actual date was 09/13/2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4808411
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« Reply #46 on: November 25, 2017, 08:13:12 AM »

Model Number 105
Device Problem Size incorrect for patient
Event Date 07/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the explanted device was discarded and will not be returned for analysis.

Manufacturer Narrative
(b)(4).

Event Description
On (b)(6) 2015 it was reported that the patient was re-implanted with a model 103 due to patient discomfort. Attempts have been made for the explanted generator but the device has not been received to date.

Event Description
It was reported on (b)(6) 2015 that the patient had a replacement with a model 105 generator in (b)(6) and is now complaining that the generator is too big. The patient states that she is uncomfortable and that it presses into her armpit. The patient wants the device replaced with a smaller model. It was noted that her md does not agree with this because she is receiving good seizure control, but did refer her to a surgeon for consult. No surgical intervention has been taken or planned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5016030
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« Reply #47 on: December 01, 2017, 02:42:09 AM »

Model Number 102R
Device Problem Migration of device or device component
Event Date 10/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received stating that the patient underwent repositioning surgery on (b)(6) 2015. It was noted that surgery was not to preclude a serious injury to the patient but for patient comfort. The physician indicated that trauma most like had occurred which contributed to the reported event and confirmed that a non-absorbable suture was used for the initial implant procedure; however, the generator had rotated 180 degrees around the suture.

Event Description
It was reported that the vns patient's device had migrated under the armpit. The patient was scheduled for repositioning surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5179328
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« Reply #48 on: December 05, 2017, 01:48:51 AM »

Model Number 103
Event Date 10/22/2015
Event Type Injury
Event Description
New information was received stating that the patient underwent a generator explant and replacement. Follow up with the treating neurologist indicated that he believed the inability to communicate with the device was due to the migration of the generator. The neurologist stated that he does not believe the lead was replaced and indicated that the new generator is functioning properly. Requests for additional relevant information from the surgeon have been unsuccessful to date. Requests to obtain the explanted generator for product analysis have been unsuccessful to date.

Event Description
It was confirmed that only the patient's generator was replaced during the surgery due to migration. Product return attempts have been unsuccessful to date.

Event Description
It was reported that the vns patient was referred for surgery as the patient's device was unable to be interrogated due to end of service. A battery life calculation using the available programming history showed - 10 years remaining. Follow-up revealed that the patient's device had migrated deep into the armpit of the patient and that the device was unable to be interrogated. It was noted that the patient's device was always difficult to locate. The physician's office stated that it was unknown if the device was actually at end of service. Trauma or any other external/contextual factors were not believed to have caused or contributed to the event. It is unknown whether a non-absorbable suture was used to secure the generator. The patient was referred for surgery but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5249128
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dennis100
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« Reply #49 on: December 05, 2017, 01:49:47 AM »

Model Number 103
Device Problems Loss of or failure to bond; Migration of device or device component; Material Protrusion Event Date 04/07/2015
Event Type Injury
Event Description
It was reported that the vns patient's generator had migrated under her armpit a few weeks ago and causing pain at the generator site. The generator later moved back to the original implant site but it was noted that leads were protruding at the generator and electrode sites. The patient underwent surgery on (b)(6) 2015 to reposition the device. During the procedure, the surgeon did not observe a suture securing the lead. Patient manipulation or trauma is not believed to have caused or contributed to the event.

Event Description
It was reported that the vns patient continued that have issues following repositioning surgery. The patient stated that her neck area was still tight and painful. She described the issue had started as a small lump in her throat but then became ¿the size of a golf ball¿ that caused pain when eating, swallowing, or moving her neck/throat. Follow-up with the surgeon¿s office revealed that the patient had a post-operative appointment on (b)(6) 2015, and no issues were noted at the patient¿s neck region. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5253695
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dennis100
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« Reply #50 on: December 06, 2017, 02:53:02 AM »

Model Number 103
Device Problems Migration of device or device component; No Known Device Problem
Event Date 12/04/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a patient fell during a seizure that was caused by stress and hit her neck on a table. The patient reported that her generator migrated up towards her collarbone. The company representative saw that the generator was in a position that is commonly placed by surgeons. The patient did have a large bruise on her neck, from under the chin down to the bottom of the neck. Diagnostics were performed, which were within normal limits. X-rays were performed, and they showed that the generator was situated near the left armpit of the patient. The surgeon who placed the generator saw the x-rays, and he stated that the generator was in a place that would be considered normal for how he implants generators. The patient did have a circular bruise about 2 inches more medial than where the generator was observed to be in the x-rays. The location of the bruise is where the patient claimed that the generator was prior to the fall. The patient was referred for revision surgery to ensure the correct placement of the generator. No surgical intervention has occurred to date. Attempts for further information were unsuccessful to date.

Event Description
Clinic notes were received for the patient's appointment with the physician. The patient's generator was displaced and was painful, causing the patient to have reduced ability to mover her left shoulder and arm. The physician stated that the displacement was traumatic (due to a fall from the year before), and the pain in the left armpit and chest started the past few months. The patient also could feel the generator moving towards the axilla. The physician noted that the lead was not prominent before, but now he could see the lead clearly as it was being pulled on by the generator migration. The physician referred the patient for surgery to get a new generator and fix the migration. No surgical intervention has occurred to date.

Event Description
The physician did believe that the cause of the bruise was from the generator being displaced laterally from the fall. Pocket revision surgery was planned due to the migration of the generator. However, the patient saw her neurologist again instead of going to see the surgeon. The neurologist decided that the generator was in a normal position, which was previously confirmed by the surgeon, and would not require surgery.

Event Description
The patient had generator replacement surgery due to migration/pain. The device was explanted by the hospital. Therefore, no analysis could be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5337448
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dennis100
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« Reply #51 on: December 07, 2017, 02:04:59 AM »

Model Number 106
Device Problem No Information
Event Date 12/11/2015
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
Follow up communication indicated that the patient's generator was actually implanted in her left armpit. Additionally, it was indicated that the patient was a regular smoker. This was the same location that her previous generator was located. No additional pertinent information has been received to date.

Event Description
It was reported that the patient developed a post-surgical infection. The infection presented as red streaking down the patient's left arm, and she was treated with antibiotics. The symptoms of infection had reportedly resolved at that time. Subsequently, the patient visited the emergency room with the red streaking returning and accompanied by pain and swelling in the left arm. The physician ruled out deep-vein thrombosis, and concluded with a diagnosis of post-operative thrombophlebitis. No interventions for the thrombophlebitis have occurred. The patient was not admitted to the hospital. The notes received from the physician appear to indicate that the patient has her generator implanted in the left arm. A review of device history records showed that the generator was sterilized prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5397383
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« Reply #52 on: December 08, 2017, 11:26:46 PM »

Model Number 106
Device Problem No Known Device Problem
Event Date 04/26/2017
Event Type Injury
Manufacturer Narrative

Event Description
Patient's vns is migrating and causing her a lot of discomfort. The patient has been seizure free but she would like to change the location of her device as it is kind of painful under her left arm pit. No known surgical interventions have occurred to date. No other relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7042673
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« Reply #53 on: December 09, 2017, 01:38:23 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 10/04/2017
Event Type Injury
Event Description
Report received from clinic notes that a patient was seen in the clinic and her generator was easily palpable in the left chest and axilla. The generator was reportedly extremely mobile and could be flipped over under the skin from side to side. Further information was received that the patient was scheduled to get a generator replacement with the intention of providing the patient with a new generator and correcting the migrated device at the same time. The patient's current generator battery was reportedly depleting, so the neurologist indicated it would be good to replace the device. It was also reported that the migration was needed because there was concern that the flipping of the generator would damage the lead wire. No surgical intervention has occurred to date and no further relevant information has been received.

Manufacturer Narrative
Device evaluation is not necessary because the reported event of migration has been determined to not be related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6993054
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« Reply #54 on: December 11, 2017, 03:11:02 AM »

Model Number 304-20
Event Date 01/01/2016
Event Type Injury
Manufacturer Narrative
Information received the day the initial mdr was submitted was inadvertently omitted from the initial mdr.

Event Description
The patient was set to have surgery but it was determined that no replacement of the generator was necessary. The leads were manipulated and it was stated that the device seems to be ok. Clarification from the nurse was obtained which showed that the reason for the planned replacement was solely for the patient's neck pain. There was no chest pain, only pain in the neck area of the vns. She confirmed the battery was still good and impedance levels were fine. The surgeon also took some x-rays and determined the positioning of the tie-down (or what they called the elastic flange) was likely causing her discomfort against the skin. She stated that they dissected the flange out and because there was enough scarring around the lead they did not need to secure it again. The procedure was for patient comfort.

Manufacturer Narrative

Event Description
Notes dated (b)(6) 2016 state that the patient's battery is reported to be near end of service and requires replacement. Notes dated (b)(6) 2016 state that one week prior the patient had onset of shooting pain in her left axilla. The notes state that the patient was seen urgently by the neurosurgeon upon complaints of pain/discomfort of concern for vns malfunctioning. Noted to have protruding piece of chest wall tissue of concern for a surgical clip vs wire/generator attachment. Vns was interrogated and found to have normal impedance. Chest wall protrusion of concern for adhesions that may be contributing to muscular skeletal discomfort. The vns was turned off for 20-30 minutes and then turned back on, patient was observed during this time for side effects/adverse effects and no discomfort was noted. It was indicated that on (b)(6) 2016 the patient had surgery. The generator was not changed but it was indicated that something was done to the leads although it is not clear at this time what they did. Post-op impedance was still within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5435350
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dennis100
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« Reply #55 on: December 13, 2017, 02:33:49 AM »

Model Number 103
Event Date 01/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
Analysis of the generator was completed on 03/21/2016. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Pre-operative diagnostics performed prior to surgery for the generator migration identified high impedance (7335 ohms). Both the lead and generator were replaced. The generator and lead were received for analysis. Analysis of the lead was completed on 03/07/2016. Note that portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils, anchor tether and the (-) green electrode were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 230mm portion quadfilar coil 1 appeared to be broken approximately 21mm from the end of the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting with mechanical damage which prevented identification of the coil fracture type. Pitting and residual material were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded open / torn area found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

Event Description
It was reported that the patient was referred for surgery due to the generator migrating under the patient's armpit and causing pain. It was reported that the patient is developmentally delayed and patient manipulation is suspected. The physician reported that the generator replacement was being performed to preclude a serious injury. It was reported that the patient was experiencing breakthrough seizures and there is concern that the vns is not working as effectively as it was before which is why the generator will be replaced when the revision surgery occurs. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5402897
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« Reply #56 on: December 31, 2017, 02:37:24 AM »

Event Type Malfunction
Event Description
It was reported by a patient that he had experienced "irregular stimulation" and painful stimulation with his vns device. The patient reported that the generator (unknown when implanted and reportedly explanted in (b)(6) 2016) caused him to have painful stimulation in the left neck and armpit, and the "irregular stimulation" to his vagus nerve caused his body to "forget how to breathe" while sleeping. The patient also reported that he had to then start using oxygen at night to make sure his body continues to breathe while he sleeps. Reportedly, the neurologist informed the patient that the irregular stimulation from the generator caused his nerve to become dependent on the stimulation to remember to breathe, so the neurologist continues to suggest that the patient be re-implanted with vns. However, the patient refused to be re-implanted after the third generator was explanted. The patient kept the third generator after explant, and the lead was left implanted. The patient also reported that vns did help reduce his seizures, but he has stress-induced grand mal seizures which were exacerbated by the painful stimulation and distress over having "defective vns devices. " he tried to hurt himself as well because of the painful stimulation and distress. No further relevant information has been received to date.

Manufacturer Narrative

Event Description
The patient reported that his third generator malfunctioned and shocked his jaw and teeth to the point where he had to get dentures. He reported that he could not get the lead removed where he lived due to the damage on his nerve from stimulation. Neither of the patient's previous surgeons were aware of a third generator being implanted. Attempts for further information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6031775
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« Reply #57 on: January 01, 2018, 02:44:08 AM »

Model Number 105
Event Date 10/13/2016
Event Type Injury
Event Description
The explanted generator and lead were received by the manufacturer for analysis. Product analysis is expected; however, it has not been completed to date.

Event Description
Product analysis (pa) for the returned generator and lead was completed. The allegation of infection was noted to be beyond the scope of the activities performed within the pa laboratory environment. However, potential contributing factors to this condition were considered/evaluated and none were found to exist. The generator diagnostics were as expected for the programmed parameters. The electrical test showed the generator performed according to functional specifications. There were no performance or any other types of adverse conditions found with the generator. Other than typical wear and explant related observations, no other anomalies were identified with the returned portion of the lead. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that portion.

Manufacturer Narrative
(b)(4).

Event Description
It was reported the patient had an infection, which was first observed, on (b)(6) 2016. The patient's family had noted on (b)(6) 2016, prior to a normal scheduled follow-up visit on (b)(6) 2016, that they had observed some swelling and the generator implant location. The infection was confirmed on (b)(6) 2016 at the follow-up appointment and the patient had a chest ultrasound due to the infection on (b)(6) 2016. The patient underwent a full explant surgery on (b)(6) 2016. It was noted prior to surgery on (b)(6) 2016 that there was actually wound dehiscence which had occurred between (b)(6) 2016 and the surgery date. It was noted the reason for the infection is believed to be the fact that the generator was implanted in the axillary region and the patient is in a wheelchair and the sweat may be a contributing factor to the cause of the infection. Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6055616
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« Reply #58 on: January 05, 2018, 03:54:45 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 12/19/2016
Event Type Injury
Event Description
Further follow-up with the physician¿s office 03/06/2017 provided the patient had been scheduled for surgery. It was decided to perform the surgery after seeing the surgeon again and they were able to palpate it and find that it was moving after doing so. Generator replacement surgery occurred on (b)(6) 2017. The explanted device has not been received by the manufacturer to-date.

Event Description
Follow-up from the company representative provided that after the patient had been to see the surgeon, he had concluded the device has not migrated.

Event Description
It was reported to a company representative that a patient¿s generator is migrating down to the armpit and the patient has complained that it¿s painful near the muscle around the armpit area when it migrates. The physician took x-rays and it showed that it was in a normal location when the x-ray was taken but the patient can feel it moving if she pushed it and it was reported that the patient could flip the generator if she tried, although it was reported that she hasn¿t flipped it. The patient later reported that she saw the surgeon and is planning surgery to replace the battery and lead, stating that the device has migrated underneath her armpit area and with her work she gets pain in the generator site with movement. The pain is constant but increases when the device goes off. The pain will radiate up to the neck area and further to the jaw at time of stimulation. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6344391
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« Reply #59 on: January 06, 2018, 04:23:11 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 10/06/2004
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received and stated that the patient underwent vns surgery of her first implant but she had pain in the left axilla and arm. Therefore, the generator was relocated below the left clavicle and she continued to have problems with pain. The generator was then placed below the pectoral muscle without difficulties. The notes state vns stimulator insertion 2004/2006/2008 which the 2006, 2008 are likely the relocation surgeries. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7076570
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